EPIC US Feasibility Study: Use of the FiberNet® Emboli Protection Device in Carotid Artery Stenting

Completed · Not applicable

Conditions studied: Carotid Artery Stenosis

In brief

Multicenter, prospective, feasibility study designed to demonstrate the performance and safety of the Lumen Biomedical, Inc. FiberNet™ Embolic Protection System as an adjunctive device during carotid artery percutaneous intervention using the Guidant Acculink carotid stent in high surgical risk patients.

Key facts

Study ID

NCT00346515

Run by

Lumen Biomedical

People needed

30

Starts

2006-06-01

Expected to finish

2008-01-01

Last updated by the study team

2008-10-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• One or more of the high surgical risk criteria.
• Candidate for percutaneous stenting with target lesion located within common or internal carotid artery.
• Symptomatic with atherosclerotic stenosis ≥ 50% or asymptomatic with atherosclerotic stenosis ≥ 70% of the carotid artery by NASCET Criteria.

You may not qualify if…

• Allergy to Heparin.
• Myocardial infarction within the last 14 days.
• Angioplasty or PTCA/PTA procedure within the past 48 hours.
• Cardiac surgery within the past 60 days.
• Planned invasive surgical procedure within 30 days.
• Stroke within the past 14 days.
• Transient ischemic neurological attack (TIA) or amaurosis fugax within the past 48 hours.
• Intracranial stenosis that exceeded the severity of an extracranial stenosis.
• Peripheral vascular disease of sufficient severity to prevent vascular access to the target lesion.
• Total occlusion of the target vessel.
• Lesion within 2cm of the ostium of the common carotid artery.
• A stenosis that is known to be unsuitable for stenting because of one or more of:
• Tortuous or calcified anatomy proximal or distal to the stenosis
• Presence of visual thrombus
• Pseudo occlusion ('string sign')
• Serial lesions that requires more then one stent to cover entire lesion.
• Procedural complication prior to introduction of the FiberNet device into the body.

Where it is running

• Hoag Hospital — Newport Beach, California, United States
• Washington Adventist Hospital — Takoma Park, Maryland, United States
• Riverside Methodist Hospital — Columbus, Ohio, United States
• North Central Heart Institue — Sioux Falls, South Dakota, United States

Full record on ClinicalTrials.gov

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